Strategic Audit Solutions for Superior Quality
SUPPORT
AUDIT
Our Medical Device Auditing Solutions act as your independent quality assurance, ensuring compliance and mitigating risks. We streamline the auditing process, enabling you to focus on healthcare innovation with confidence.
SUPPORT
OUR
Working with you across all your auditing needs.
AUDIT MANAGEMENT
Helping simplify and well-organise the workflow and collaboration process of compiling audits.
SUPPLY CHAIN AUDITS
Working with your supply chain per the Supplier Quality Agreement, ensuring compliance with relevant regulatory requirements, regulations and standards.
INSPECTION READY
We can help you get ready for inspection. We offer a proactive process of 'getting ready' for an inspection by a regulatory authority (such as FDA).
INTERNAL AUDITS
Performed by a qualified Lead Auditor, from within your organisation who is independent of the activities being audited.
AUDIT FACILITATION
Effective Audit facilitation is a crucial part of any audit process. We conduct goal-oriented communications, mediation and negotiation with and between the process partners who are to be audited.
REMEDIATION
Supporting your stakeholders to effectively address and resolve observations and findings raised.